The following data is part of a premarket notification filed by Personal Products Co. with the FDA for Assure-breathable Panty Liners/scent.
Device ID | K841312 |
510k Number | K841312 |
Device Name: | ASSURE-BREATHABLE PANTY LINERS/SCENT |
Classification | Pad, Menstrual, Scented |
Applicant | PERSONAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HHL |
CFR Regulation Number | 884.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-30 |
Decision Date | 1984-08-20 |